DECEMBER 2006

WEEK ENDING DECEMBER 2

PRODUCT Tetracaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 12 x 0.7 mL Single use containers, Sterile, Rx only, NDC 59390-181-07, 
CODE Lot: 05368, Exp. 09/07
RECALLING FIRM/MANUFACTURER Altaire Pharmaceuticals, Inc., Aquebogue, NY,
REASON Subpotent
VOLUME OF PRODUCT IN COMMERCE 35,664 single use units
DISTRIBUTION CA and MI

PRODUCT Neaclear Liquid Oxygen Scar Advantage, Hydrocortisone 0.5%, 1.0 oz (30 ml) bottles
CODE Lots: 6994 and 8050
RECALLING FIRM/MANUFACTURER Diversified Manufacturing Corp, Newport, MN, 
REASON Defective container
VOLUME OF PRODUCT IN COMMERCE 20,000 bottles estimated
DISTRIBUTION IL

PRODUCT 

Acetaminophen caplets, 500 mg, packaged in bottles of 24, 50, 65, 100, 250 and 500 caplets under the following brand names: 

American Fare Extra Strength Pain Relief Made for Kmart Corporation, NDC 49738-484-78;
Berkley & Jensen Extra Strength Pain Relief, Dist. by BJWC;
Best Yet Extra Strength Non-Aspirin, Dist. by Fleming;
Brite-Life Extra Strength Pain Reliever, Dist. by AmerisourceBergen, NDC 24385-484-71;
Brooks Acetaminophen Extra Strength, Dist. by Maxi Drug, Inc. d/b/a/ Brooks Pharmacy;
CareOne Pain Relief Extra Strength, Dist. by American Sales Company;
Extra Strength CounterAct Pain, Dist by Melaleuca, Inc.;
CVS Pharmacy Extra Strength Pain Relief, Dist. by CVS Pharmacy, Inc.;
DG Guarantee Extra Strength Pain Relief, Dist. by Dolgencorp, Inc.;
Eckerd Extra Strength Non-Aspirin Pain Relief, Dist. by Eckerd Drug Co., NDC 19458-5013-2;
Equaline Extra Strength Pain Relief, Dist. By Albertsons Inc., NDC 41163-484-78;
Equate Extra Strength Pain Reliever, Dist. by Wal-Mart Stores, Inc., NDC 49035-484-78;
Family Pharmacy Extra Strength Pain Reliever, Dist. by Family Pharmacy, NDC 52735-710-12;
Food Lion Pain Relief, extra strength, Dist. By Food Lion LLC, NDC 55316-484-78;
FormuCare Pain Relief, Extra Strength, Dist. by Access Business Group International LLC;
Good Neighbor Pharmacy Extra Strength Pain Reliever, Dist by AmerisourceBergen, NDC 24385-484-78;
GoodSense Extra Strength Pain Relief, Dist by Perrigo Co, NDC 0113-0484-78;
H-E-B Pain Relief, Extra Strength, Dist. by H-E-B, NDC 37808-484-78;
Hannaford Pain Reliever, extra strength, Dist. by Hannaford Bros. Co., NDC 41268-484-78;
Healthy Generations extra strength non-aspirin Pain Relief, Dist. by Supervalu Inc., NDC 38045-484-78;
HyVee Extra Strength non-aspirin Pain Relief, Dist. by Hy-Vee, Inc.;
Kroger Pain Relief, Extra Strength, Dist. by the Kroger Co., NDC 30142-484-78;
Longs Wellness Extra Strength Pain Relief, Dist. by Longs Drugs, NDC 12333-9058-1;
Medic Extra Strength Acetaminophen, Dist. by Winn Dixie Stores, Inc.;
Meijer Pain Relief, Extra Strength, Dist. by Meijer Distribution, Inc., NDC 41250-484-78;
Pathmark Extra Strength Acetaminophen, Dist. by Pathmark Stores, Inc.,
Publix Extra Strength Pain Relief, Dist. by Publix Super Markets, Inc., NDC 56062-484-78;
Roundy’s Quality Extra Strength Pain Reliever, Dist. by Roundy’s Inc.;
Safeway Extra Strength non-aspirin Acetaminophen, Dist. by Safeway, Inc., NDC 21130-484-78;
ShopRite Extra Strength Non-Aspirin, Dist. by Wakefern Food Corp.;
Sunmark Pain Relief, Extra Strength, Dist by McKesson, NDC 49348-042-10;
Swan Extra Strength Pain Reliever/Fever Reducer, Dist. by Cumberland Swan, NDC 0869-9484-71;
The Medicine Shoppe Extra Strength Medi-Tabs, Dist. by Medicine Shoppe International, Inc., NDC 49614-123-78;
Today's Health Extra Strength Pain Reliever, Dist. by Warehouse Concepts, Inc., NDC 38309-484-78 and
TopCare Extra Strength Pain Relief, Dist. by Topco Associates LLC, NDC 36800-484-78,
CODE
Lots 5CE0507, exp. 11/06; 5CE0333, exp. 11/06; 5CE0347, exp. 11/06; 5CE0348, exp. 11/06; 5CE0350, exp. 12/06; 5CE0461, exp. 12/06; 5CE0601, exp. 12/06; 5CE0602, exp. 12/06; 5CE0606, exp. 01/07; 5CE0607, exp. 01/07; 5CE0608, exp. 12/06; 5CE0874, exp. 01/07; 5CE0876, exp. 01/07; 5CE0877, exp. 01/07; 5CE0878, exp. 01/07; 5CE0879, exp. 01/07; 5CE1022, exp. 01/07; 5CE1023, exp. 01/07; 5CE1024, exp. 01/07; 5CE1025, exp. 01/07; 5CE1026, exp. 01/07; 5CE1088, exp. 09/06; 5CE1089, exp. 12/06; 5DE0121, exp. 01/07; 5DE0122, exp. 01/07; 5DE0322, exp. 01/07; 5DE0464, exp. 01/07; 5DE0465, exp. 01/07; 5DE0466, exp. 01/07; 5DE0476, exp. 01/07; 5DE0477, exp. 01/07; 5DE0746, exp. 02/07; 5DE0867, exp. 02/07; 5DE0868, exp. 02/07; 5DE0913, exp. 02/07; 5DE0982, exp. 02/07; 5DE0983, exp. 02/07; 5EE0055, exp. 02/07; 5EE0056, exp. 02/07; 5EE0057, exp. 02/07; 5EE0381, exp. 12/06; 5EE0382, exp. 01/07; 5EE0383, exp. 12/06; 5EE0384, exp. 01/07; 5EE0385, exp. 02/07; 5EE0386, exp. 02/07; 5EE0416, exp. 02/07; 5EE0417, exp. 02/07; 5HE0455, 5HV0249, 5JE0105, exp. 05/07; 5JE0142, exp. 04/07; 5JE0467, exp. 06/07; 5JE0469, exp. 07/07; 5JE0471, exp. 07/07; 5JE0472, exp. 04/07; 5JE0474, exp. 07/07; 5JE0582, exp. 07/07; 5JE0610, exp. 07/07; 5JE0713, exp. 06/07; 5JE0714, exp. 07/07; 5JE0723, exp. 04/07; 5JE0731, exp. 07/07; 5JE0936, exp. 07/07; 5JE0937, exp. 08/07; 5JE0938, exp. 08/07; 5JE0939, exp. 08/07; 5JE0939, exp. 08/07; 5JE0940, exp. 07/07; 5KE0060, exp. 07/07; 5KE0061, exp. 08/07; 5KE0066, exp. 08/07; 5KE0260, exp. 07/07; 5KE0306, exp. 07/07; 5KE0308, exp. 07/07; 5KE0396, exp. 08/07; 5KE0427, exp. 08/07; 5KE0428, exp. 07/07; 5KE0488, exp. 08/07; 5KE0489, exp. 08/07; 5KE0530, exp. 08/07; 5KE0531, exp. 08/07; 5KE0532, exp. 08/07; 5KE0579, exp. 08/07; 5KE0838, exp. 08/07; 5KE0955, exp. 04/07; 5KE0988, exp. 08/07; 5KE1063, exp. 08/07; 5KV0623, exp. 08/07; 5KV0624, exp. 08/07; 5LE0074, exp. 08/07; 5LE0075, exp. 09/07; 5LE0076, exp. 09/07; 5LE0264, exp. 09/07; 5LE0309, exp. 07/07; 5LE0329, exp. 09/07; 5LE0330, exp. 09/07; 5LE0399, exp. 09/07; 5LE0400, exp. 09/07; 5LE0419, exp. 09/07; 5LE0522, exp. 09/07; 5LE0612, exp. 09/07; 5LE0736, exp. 09/07; 5LE0791, exp. 09/07; 5LE0793, exp. 09/07; 5LE0794, exp. 09/07; 5LE0843, exp. 09/07; 5LE0853, exp. 09/07; 5LV0537, exp. 08/07; 5ME0011, exp. 09/07; 5ME0012, exp. 10/07; 5ME0031, exp. 09/07; 5ME0065, exp. 09/07; 5ME0180, exp. 10/07; 5ME0181, exp. 10/07; 5ME0265, exp. 10/07; 5ME0266, exp. 10/07; 5ME0269, exp. 10/07; 5ME0375, exp. 10/07; 5ME0379, exp. 10/07; 5ME0380, exp. 10/07; 5ME0403, exp. 11/07; 5ME0458, exp. 10/07; 5ME0459, exp. 09/07; 5ME0488, exp. 10/07; 5ME0603, exp. 10/07; 5ME0669, exp. 10/07; 5ME0685, exp. 10/07; 5ME0688, exp. 11/07; 5ME0694, exp. 09/07; 5ME0783, exp. 10/07; 5ME0786, exp. 09/07; 5ME0788, exp. 079/07; 5ME0822, exp. 09/07; 5ME0825, exp. 09/07; 5ME0829, exp. 10/07; 5ME0920, exp. 11/07; 5MV0309, exp. 09/07; 5MV0515, exp. 09/07; 5MV0565, exp. 09/07; 5MV0566, exp. 09/07; 5MV0568, exp. 10/07; 5MV0571, exp. 10/07; 6AE0008, exp. 11/07; 6AE0009, exp. 10/07; 6AE0017, exp. 11/07; 6AE0071, exp. 10/07; 6AE0144, exp. 11/07; 6AE0183, exp. 10/07; 6AE0199, exp. 11/07; 6AE0277, exp. 09/07; 6AE0278, exp. 10/07; 6AE0279, exp. 11/07; 6AE0280, exp. 11/07; 6AE0281, exp. 11/07; 6AE0314, exp. 10/07; 6AE0324, exp. 11/07; 6AE0506, exp. 11/07; 6AE0507, exp. 10/07; 6AE0567, exp. 11/07; 6AE0568, exp. 11/07; 6AE0569, exp. 12/07; 6AE0708, exp. 11/07; 6AE0712, exp. 11/07; 6AE0719, exp. 11/07; 6AE0726, exp. 11/07; 6AE0834, exp. 12/07; 6AE0835, exp. 12/07; 6AE0847, exp. 11/07; 6AV0092, exp. 08/07; 6AV0093, exp. 10/07; 6BE0068, exp. 11/07; 6BE0086, exp. 11/07; 6BE0087, exp. 11/07; 6BE0120, exp. 11/07; 6BE0160, exp. 11/07; 6BE0162, exp. 12/07; 6BE0168, exp. 12/07; 6BE0201, exp. 12/07; 6BE0279, exp. 12/07; 6BE0378, exp. 12/07; 6BE0395, exp. 12/07; 6BE0466, exp. 11/07; 6BE0535, exp. 12/07; 6BE0581, exp. 12/07; 6CE0064, exp. 12/07; 6CE0065, exp. 12/07; 6EV0392, exp. 11/07; 6FE0051, exp. 04/09; 6FE0182, exp. 04/09; 6FE0305, exp. 04/09; 6FE0377, exp. 04/09; 6FE0478, exp. 04/09; 6FE0479, exp. 04/09; 6FE0659, exp. 04/09; 6FV0404, exp. 04/09; 6FV0435, exp. 04/09; 6GE0108, exp. 04/09; 6GE0303, exp. 05/09; 6GE0436, exp. 05/09; 6GE0438, exp. 05/09; 6GE0654, exp. 05/09; 6GE0655, exp. 04/09; 6GE0657, exp. 05/09; 6GE0659, exp. 05/09; 6GE0660, exp. 05/09; 6GV0258, exp. 05/09; 6GV0260, exp. 05/09; 6HE0051, exp. 04/09; 6HE0091, exp. 06/09; 6HE0404, exp. 04/09; 6HE0422, exp. 04/09; 6HE0536, exp. 04/09; 6HE0566, exp. 07/09; 6HE0567, exp. 05/09; 6HE0568, exp. 05/09; 6HE0639, exp. 07/09; 6HE0640, exp. 07/09; 6HE0641, exp. 07/09; 6HE0673, exp. 05/09; 6HE0741, exp. 07/09; 6HE0742, exp. 07/09; 6HE0744, exp. 04/09; 6HE0823, exp. 07/09; 6HE0824, exp. 07/09; 6HV0167, exp. 04/09; 6HV0168, exp. 04/09; 6HV0170, exp. 04/09; 6HV0171, exp. 05/09; 6HV0226, exp. 04/09; 6HV0277, exp. 05/09; 6HV0278, exp. 06/09; 6HV0442, exp. 07/09; 6HV0453, exp. 07/09; 6HV0455, exp. 07/09; 6JE0016, exp. 07/09; 6JE0095, exp. 07/09; 6JE0096, exp. 07/09; 6JE0116, exp. 08/09; 6JE0346, exp. 07/09; 6JE0483, exp. 07/09; 6JE0484, exp. 07/09; 6JE0485, exp. 07/09; 6JE0680, exp. 08/09; 6JE0681, exp. 08/09; 6JE0682, exp. 07/09; 6KE0101, exp. 08/09; 6KE0106, exp. 08/09; 6KE0107, exp. 08/09; 6KE0108, exp. 08/09; 6KE0231, exp. 08/09; 6KE0252, exp. 08/09; 6KE0270, exp. 04/09; 6KE0271, exp. 07/09; 6KE0272, exp. 08/09; 6KE0274, exp. 08/09; 6KE0276, exp. 08/09; 6KE0364, exp. 08/09; 6KE0527, exp. 08/09; 6KE0529, exp. 08/09; 6KE0538, exp. 08/09; 6KE0562, exp. 08/09 and 6KE0722, exp. 08/09;
plus retailer display case overwrap lots 5CV0082, 5CV0251, 5CV0259, 5CV0336, 5CV0404, 5CV0471, 5DV0189, 5DV0293, 5DV0343, 5DV0347, 5DV0399, 5DV0431, 5DV0445, 5EV0148, 5EV0310, 5EV0313, 5FV0144, 5FV0302, 5HV0249, 5KV0157, 5KV0301, 5KV0622, 5LV0190, 5LV0393, 5LV0394, 5LV0396, 5LV0397, 5LV0170, 5LV0458, 5LV0506, 5MV0491, 6AV0118, 6AV0123, 6AV0125, 6AV0126, 6AV0279, 6AV0403, 6AV0404, 6AV0405, 6AV0406, 6AV0407, 6AV0409, 6AV0411, 6AV0412, 6AV0414, 6AV0460, 6AV0461, 6AV0462, 6AV0463, 6AV0464, 6AV0465, 6AV0466, 6AV0467, 6AV0468, 6AV0491, 6AV0494, 6AV0496, 6AV0504, 6AV0520, 6AV0521, 6AV0522, 6AV0523, 6AV0535, 6AV0538, 6AV0539, 6AV0540, 6AV0543, 6AV0544, 6AV0545, 6AV0614, 6BV0114, 6BV0115, 6BV0116, 6BV0117, 6BV0118, 6BV0119, 6BV0120, 6BV0208, 6BV0354, 6CV0149, 6CV0536, 6DV0180, 6DV0181, 6DV0182, 6DV0183, 6DV0185, 6DV0186, 6DV0188, 6DV0217, 6DV0366, 6EV0196, 6EV0262, 6EV0274, 6EV0276, 6EV0286, 6EV0287, 6EV0316, 6EV0320, 6EV0334, 6EV0335, 6EV0388, 6EV0395, 6FV0405, 6GV0139, 6GV0264, 6GV0272, 6GV0316, 6JV0320, 6JV0398, 6JV0399, 6JV0400, 6KV0122, 6KV0127, 6KV0221, 6KV0232, 6KV0234, 6KV0262, 6KV0282, 6KV0284, 6KV0291 and 6KV0309
RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan, MI, 
REASON Presence of foreign substance; Caplets may have small pieces of metal imbedded within them.
VOLUME OF PRODUCT IN COMMERCE 11,112,836 bottles
DISTRIBUTION Nationwide

PRODUCT Xigris® (Drotrecogin alfa, activated), lyophilized powder for intravenous use, 5 mg vial, Rx only, NDC 0002-7559-01, Lilly item code VL7559,
CODE Lot: A10242, Exp. 2/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eli Lilly and Company, Indianapolis, IN, 
Manufacturer: DSM Pharmaceuticals, Inc., Greenville, NC. 
REASON The vial stopper may generate particulates or collapse during reconstitution of the drug.
VOLUME OF PRODUCT IN COMMERCE 322/5 mg vials
DISTRIBUTION AZ, CA, CO, and WA

PRODUCT Oxygen, Compressed USP, medical gas in aluminum cylinder, sizes D, E, DA, EA, M4, M6, M9, M22, 
CODE WT02T226B, WT03T236I, WT01T250K, WT04T262D, WT05T270Q, WT00T282P, WT02T226I , WT04T240B, WT01T250N, WT04T262F, WT05T271B, WT00282N, WT02T226M, WT04T240F, WT01T250P, WT04T263K, WT05T271I , WT01T283A, WT02T227F, WT04T240K, WT01T251G, WT04T263M, WT05T271K, WT01T283D, WT02T227J, WT04T241C, WT02T254A, WT04T263N, WT05T271O, WT01T283I, WT02T229A, WT04T241F, WT02T254C, WT04T263O, WT05T272C, WT01T283M, WT02T229D, WT04T241L, WT02T254L, WT047263P, WT06T272F, WT01T283P, WT02T229E, WT04T241M, WT02T255B, WT04T264D, WT00T275D, WT03T230A, WT04T242D, WT02T255C, WT04T264M, WT00T275H, WT03T233F, WT04T242G, WT02T255F, WT04T264O, WT00T278A, WT03T233G, WT05T243B, WT02T255G, WT04T265D, WT00T278B, WT03T234B, WT05T243D, WT03T257I, WT04T265F, WT00T278C, WT03T234F, WT01T249B, WT03T257N, WT04T266A, WT00T278D, WT03T234H, WT01T249D, WT03T258D, WT04T268B, WT00T278H, WT03T235B, WT01T249E, WT03T258I, WT04T268D, WT00T279B, WT03T236A, WT01T249G, WT03T261A, WT04T269C, WT00T279C, WT03T236B, WT01T249J, WT03T261F, WT04T269E, WT00T279E, WT03T236K, WT01T250B, WT03T261I, WT04T269G, WT00T279F, WT03T236M, WT01T250D, WT03T261J, WT04T269H, WT00T282H, WT03T236F, WT01T250F, WT04T262B, WT04T269L, WT00T282J
RECALLING FIRM/MANUFACTURER Airgas South, Inc., Albany, GA,
REASON Rinse water from external cleaning may have contaminated product resulting in residual odor of cleaning solution.
VOLUME OF PRODUCT IN COMMERCE 2,774 cylinders
DISTRIBUTION GA

PRODUCT Doxepin Hydrochloride Capsules, USP, 25 mg, Rx only, 1000 count bottles, NDC 0591-5630-10
CODE Lot: L6G0879, Exp. 8/31/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories, Inc., Corona, CA, 
Manufacturer: Watson Laboratories, Inc., Carmel, NY. 
REASON Defective containers (loose caps)
VOLUME OF PRODUCT IN COMMERCE 167/1000 count bottles
DISTRIBUTION Nationwide

WEEK ENDING DECEMBER 9

PRODUCT Ultravist (brand of iopromide) Injection, 370mg I/mL, 50, 75, 100, 125, 150, 200, 250, and 500 mL Sterile Solution Vials, Rx only, Not for Intrathecal Use, NDC 50419-346-58, 
CODE All unexpired lots, all presentations. Item #, Size (mL), Lot, Exp: 34605, 50, 121082T, 12/2006; 34605, 50, 142682T, 02/2007; 34605, 50, 162002T, 04/2007; 34605, 50, 172692T, 05/2007; 34605, 50, 182012T, 06/2007; 34605, 50, 53511B, 07/2008. 34607, 75, 151532T, 03/2007; 34607, 75, 172242T, 05/2007. 34610, 100, 080282T, 08/2006; 34610, 100, 100612T, 10/2006; 34610, 100, 141322T, 02/2007; 34610, 100, 141332T, 02/2007; 34610, 100, 181882T, 06/2007; 34610, 100, 232652T, 11/2007; 34610, 100, 232662T, 11/2007; 34610, 100, 52508A, 04/2008; 34610, 100, 53513D, 08/2008; 34610, 100, 53514A, 08/2008; 34610, 100, 61526B, 01/2009; 34610, 100, 61531E, 03/2009; 34610, 100, 61533A, 03/2009. 34612, 125, 101762T, 10/2006; 34612, 125, 202222T, 08/2007; 34612, 125, 41500A, 01/2007; 34612, 125, 61501A, 03/2009. 34615, 150, 100602T, 10/2006; 34615, 150, 121202T, 12/2006; 34615, 150, 172462T, 05/2007; 34615, 150, 202412T, 08/2007; 34615, 150, 222472T, 10/2007; 34615, 150, 44501E, 10/2007; 34615, 150, 52502A, 04/2008; 34615, 150, 53504B, 09/2008; 34615, 150, 61506A, 03/2009. 34620, 200, 110912T, 11/2006; 34620, 200, 120922T, 12/2006; 34620, 200, 171832T, 05/2007; 34620, 200, 242852T, 12/2007; 34620, 200, 53512C, 09/2008; 34620, 200, 61520B, 03/2009. 34625, 250, 101542T, 10/2006; 34625, 250, 133092T, 01/2007; 34625, 250, 143102T, 02/2007; 34625, 250, 61504A, 01/2009, (Release date 4/11/2006); 34625, 250, 61504A, 01/2009, (Release date 4/28/2006). 34650, 500, 111092T, 11/2006. 34658, 500, 142642T, 02/2007; 34658, 500, 182282T, 06/2007; 34658, 500, 192062T, 07/2007; 34658, 500, 212442T, 09/2007; 34658, 500, 262832T, 02/2008; 34658, 500, 263062T, 02/2008,(Release date 4/20/2006); 34658, 500, 263062T, 02/2008, (Release date 5/17/2006); 34658, 500, 263072T, 02/2008; 34658, 500, 263072T, 02/2008; 34658, 500, 52504F, 04/2008; 34658, 500, 53508A, 03/2008; 34658, 500, 61516B, 03/2009. The following are SAMPLE Lots: 34691, 100, 141322T, 02/2007; 34691, 100, 181882T, 06/2007; 34691, 100, 232662T, 11/2007; 34691, 100, 53513D, 08/2008, (Release date 3/20/2006); 34691, 100, 53513D, 08/2008, (Release date 5/31/2006); 34691, 100, 53514A, 08/2008. 34695, 150, 100602T, 10/2006; 34695, 150, 222472T, 10/2007; 34695, 150, 52502A, 04/2008; 34695, 150, 53504B, 09/2008, (Release date 1/31/2006); 34695, 150, 53504B, 09/2008, (Release date 4/19/2006). 34697, 500, 111092T, 11/2006; 34697, 500, 262832T, 02/2008; 34697, 500, 52504F, 04/2008; 34697, 500, 53508A, 09/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Berlex, Inc., Wayne, NJ
Manufacturer: Schering Ag (Wedding Plant), Berlin, Germany.
REASON Presence of precipitate
VOLUME OF PRODUCT IN COMMERCE 854,629 vials
DISTRIBUTION Nationwide

PRODUCT Megatope (Iodinated I 131 Albumin Injection USP), 4mL vials; each mL contains 10mg protein (human albumin), 16mg dibasic sodium phosphate, 1.6mg monobasic sodium phosphate, not more than 0.4mg guanidine HCl, sodium chloride and 9mg benzyl alcohol; NDA #17-837; manufactured by Iso-Tex Diagnostics, Inc., Friendswood, TX 77546, 
CODE Lot #: M62010-115
RECALLING FIRM/MANUFACTURER Iso-Tex Diagnostics, Inc., Friendswood, TX, 
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 1/4mL vials
DISTRIBUTION TN

PRODUCT Citalopram HBr Tablets, 20 mg, 100 Tablet bottles, Rx only, NDC 0258-3696-01, 
CODE Lot #: P12047, Exp. Date: 6/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inwood Laboratories, Inc., Commack, NY, 
Manufacturer: Forest Laboratories Ireland, Ltd., Dublin, Ireland. 
REASON Presence of foreign substance -- potential metal contamination.
VOLUME OF PRODUCT IN COMMERCE 11,276 bottles of 100 Tablets
DISTRIBUTION Nationwide and PR

WEEK ENDING DECEMBER 16

Alcon Announces Recall of Systane® Free LIQUID GEL Lubricant Eye Drops 

Alcon Laboratories, Inc., announced today a recall of Systane® Free LIQUID GEL lubricant eye drops. No other formulations of Systane® lubricant eye drops are included in this recall. This recall is in response to 11 consumer reports citing the presence of foreign material. Alcon has distributed over 5 million bottles of Systane® Free LIQUID GEL since its introduction in January 2006.

After testing particles from the opened, partially used bottles that were returned to Alcon, the company identified the foreign material as mold. However, because of the characteristics of these molds, the development of an infection is considered unlikely.  

Retailers, distributors, customers and consumers can identify if their bottles are subject to the recall by locating the words "Free" and "LIQUID GEL" on the product box or bottle. If these words are not on the bottle or box, the product is safe for use and is not subject to this recall. The picture provided shows where these words are found on the bottle and box. 

Consumers who are in possession of Systane® Free LIQUID GEL should immediately discontinue use and call 1-866-608-3936 or visit http://www.systane.com/ for instructions. The company is currently contacting retailers, distributors and eye doctors to communicate return and replacement instructions. These customers may also call 1-866-608-3936 for more information. Reply cards and pre-paid mailing slips are being provided for product return.

PRODUCT Nystatin Topical Powder, USP, 100,000 units per gram, Rx Only, 30 grams bottles, NDC 67767-112-16,
CODE Lot 5C503
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coastal Pharmaceuticals, Inc, GreenvilleNC, 
Manufacturer: Metrics Inc, Greenville,NC. 
REASON Subpotent (12 month stability)
VOLUME OF PRODUCT IN COMMERCE 2,693 bottles
DISTRIBUTION Nationwide

WEEK ENDING DECEMBER 23

PRODUCT FERO-FOLIC -500 Filmtab Tablets (Controlled Release Iron with Vitamin C and Folic Acid ), 30 Filmtab Tablets, Rx only, NDC 0074-7079-30
CODE Lots # 08-173-AA-2 Exp Date; Oct 1, 2006 // 1, 08-173-AA-22 Exp Date; Oct 1, 2006 and 15-829-AA-21 Exp Date; May 1, 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL,
Manufacturer: Abbott Pharmaceuticals PR Ltd., Barceloneta, PR. 
REASON Current Good Manufacturing Practices (cGMP) Deviations.
VOLUME OF PRODUCT IN COMMERCE 150,986 cartons
DISTRIBUTION Nationwide and Internationally

PRODUCT Antacid Liquid Antacid/Antigas (in each 5 ml teaspoon) Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg), Cooling Mint and Mint Creme, packaged in 12 and 26 fl oz bottles under the following brand labels: CVS Pharmacy, Dist by CVS Pharmacy, Inc, NDC 59779-851-35; Good Neighbor Pharmacy, Dist by AmerisourceBergen, NDC 24385-358-40; Longs Wellness, Dist by Longs Drugs, NDC 12333-9093-1; Kroger, Dist by NDC 30142-851-40; TopCare, Dist by Topco Associates LLC., NDC 36800-851-40; Equate, Dist by Wal-Mart Stores, Inc., NDC 49035-851-35; HyVee, Dist by Hy-Vee, Inc., NDC 42507-851-40; Shop Rite, Dist by Wakefern Food Corp, Elizabeth, NJ; Leader, Dist by Cardinal Health, NDC 37205-314-40; equaline, Dist by Albertsons Inc., NDC 41163-851-40; Food Lion, Dist by Food Lion, NDC 55316-851-40; Sunmark, Dist by McKesson, NDC 49348-019-39; Good Sense, Dist by Perrigo Company, NDC 0113-0851-40, 
CODE Lots 6AK0052, exp. 11/2007; 6AK0212, exp. 11/2007; 6AK0135, exp. 11/2007; 6BK0131, exp. 11/2007; 6EK0026, exp. 03/2008; 6FK0038, exp. 03/2008; 6EK0321, exp. 03/2008; 6FK0089, exp. 03/2008; 6EK0164, exp. 03/2008; 6FK0155, exp. 03/2008; 6EK0269, exp. 03/2008.
letter mailed on 11/6/06
RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan MI
REASON Subpotent, simethicone.
VOLUME OF PRODUCT IN COMMERCE 123,702 bottles
DISTRIBUTION Nationwide

WEEK ENDING DECEMBER 30

PRODUCT Benzonatate Capsules USP, 100mg softgels, 100 count bottles, NDC 50111-851-01, 
CODE Lot 24122208AA and 24122208B, Exp. 01/2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pliva, Inc., East Hanover, NJ
Manufacturer: Banner Pharmacaps Inc, High Point, NC.
REASON Failed Impurity Specification (6 and 9 month stability)
VOLUME OF PRODUCT IN COMMERCE 975,600 capsules
DISTRIBUTION Nationwide

PRODUCT 50% Urea Ointment, In a vehicle containing Vitamin E, Lactic Acid and Zinc, Rx only, Net Wt. 1.5 oz. (45g), For external use only, Not for ophthalmic use, NDC 68032-130-45,
CODE Lot # 5553 Exp: 5/08 Lot # 5554 Exp: 5/08 Lot # 5555 Exp 5/08
RECALLING FIRM/MANUFACTURER Sonar Products, Inc., Carlstadt, NJ
REASON Degradation; product is crystallizing
VOLUME OF PRODUCT IN COMMERCE 30,084 tubes
DISTRIBUTION GA

PRODUCT Docusate Sodium Softgel Capsules, 250 mg, 100 Softgel Capsules (10X10) unit dose package, NDC 62584-684-01; Also labeled under other brand name as Good Neighbor Pharmacy Extra Strength Stool Softener, Docusate Sodium 250 mg. capsule, 100 count bottle, NDC #24385-443-78
CODE
Lot #063677, lot #063677,
Lot #062130B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services Corp., Columbus OH
Manufacturer: Tishcon Corp., Westbury, NY. 
REASON Capsules are leaking.
VOLUME OF PRODUCT IN COMMERCE 4104/100 count unit dose packages & 5761/100 count bottles.
DISTRIBUTION Nationwide